An interventional study of AcrySof IQ PanOptix Multifocal IOL and AcrySof Monofocal IOL in Cataract, sponsored by Alcon Research. Completed at 12 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.
Exclusion Criteria:
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
Device: AcrySof IQ PanOptix Multifocal IOL
AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).
Device: AcrySof Monofocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
Also known as: Model TFNT00, AcrySof® IQ PanOptix®
AcrySof Monofocal IOL Model SN60AT for single vision
Also known as: Model SN60AT, AcrySof®
Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (Day 120-180), post second eye implantation
Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (Day 120-180), post second eye implantation
Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye
The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.
Time frame: Up to Month 6 (Day 120-180), post second eye implantation
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Mean Photopic With Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (Day 120-180), post second eye implantation
Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire
The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.
Time frame: Month 6 (Day 120-180), post second eye implantation
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)
QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID
Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Subjects were recruited from 12 investigative sites located in the United States.
| Milestone | TFNT00 | SN60AT |
|---|---|---|
| Started | 129 | 114 |
| Completed | 127 | 114 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
| logMAR | TFNT00 | SN60AT |
|---|---|---|
| Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) | -0.014 ± 0.0083 | -0.039 ± 0.0087 |
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
| logMAR | TFNT00 | SN60AT |
|---|---|---|
| Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) | 0.105 ± 0.0119 | 0.529 ± 0.0127 |
The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.
| Eyes | TFNT00 | SN60AT |
|---|---|---|
| Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye | 1 | 0 |
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
| log units | TFNT00 | SN60AT |
|---|---|---|
| 3 cpd | 1.752 ± 0.2080 | 1.733 ± 0.1989 |
| 6 cpd | 1.923 ± 0.2349 | 1.940 ± 0.2328 |
| 12 cpd | 1.527 ± 0.2793 | 1.558 ± 0.2566 |
| 18 cpd | 0.993 ± 0.2874 | 1.090 ± 0.2661 |
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
| log units | TFNT00 | SN60AT |
|---|---|---|
| 3 cpd | 1.759 ± 0.1890 | 1.753 ± 0.1928 |
| 6 cpd | 1.897 ± 0.2322 | 1.971 ± 0.1952 |
| 12 cpd | 1.566 ± 0.2728 | 1.593 ± 0.2659 |
| 18 cpd | 1.037 ± 0.2762 | 1.121 ± 0.2537 |
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
| log units | TFNT00 | SN60AT |
|---|---|---|
| 1.5 cpd | 1.673 ± 0.2601 | 1.679 ± 0.2190 |
| 3 cpd | 1.717 ± 0.2397 | 1.689 ± 0.2177 |
| 6 cpd | 1.715 ± 0.2875 | 1.777 ± 0.2871 |
| 12 cpd | 1.211 ± 0.4047 | 1.290 ± 0.4384 |
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
| log units | TFNT00 | SN60AT |
|---|---|---|
| 1.5 cpd | 1.658 ± 0.2296 | 1.678 ± 0.2091 |
| 3 cpd | 1.709 ± 0.2307 | 1.692 ± 0.2089 |
| 6 cpd | 1.691 ± 0.3238 | 1.786 ± 0.2775 |
| 12 cpd | 1.129 ± 0.4146 | 1.233 ± 0.4599 |
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
| logMAR | TFNT00 | SN60AT |
|---|---|---|
| Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) | 0.070 ± 0.0108 | 0.327 ± 0.0114 |
The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.
| percentage of subjects | TFNT00 | SN60AT |
|---|---|---|
| Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire | 80.5 | 8.2 |
QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
| Participants | TFNT00 | SN60AT |
|---|---|---|
| Starbursts | 20 | 2 |
| Halos | 16 | 1 |
| Glare | 4 | 2 |
| Hazy vision | 0 | 0 |
| Blurred vision | 0 | 0 |
| Double vision | 0 | 0 |
| Dark area | 0 | 0 |
Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
| Participants | TFNT00 | SN60AT |
|---|---|---|
| Starbursts | 6 | 1 |
| Halos | 3 | 1 |
| Glare | 2 | 1 |
| Hazy vision | 0 | 1 |
| Blurred vision | 0 | 2 |
| Double vision | 0 | 0 |
| Dark area | 0 | 0 |
Collected over Implantation through study completion, an average of 7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preoperative | 0/243 (0%) | 0/243 (0%) | 1/243 (0.4%) |
| TFNT00 - 1st Eye | 0/129 (0%) | 2/129 (1.6%) | 24/129 (18.6%) |
| TFNT00 - 2nd Eye | 0/127 (0%) | 2/127 (1.6%) | 24/127 (18.9%) |
| TFNT00 - Systemic | 0/129 (0%) | 4/129 (3.1%) | 0/129 (0%) |
| SN60AT - 1st Eye | 0/114 (0%) | 2/114 (1.8%) | 10/114 (8.8%) |
| SN60AT - 2nd Eye | 0/111 (0%) | 1/111 (0.9%) | 7/111 (6.3%) |
| SN60AT - Systemic | 0/114 (0%) | 3/114 (2.6%) | 0/114 (0%) |
| Event | Preoperative | TFNT00 - 1st Eye | TFNT00 - 2nd Eye | TFNT00 - Systemic | SN60AT - 1st Eye | SN60AT - 2nd Eye | SN60AT - Systemic |
|---|---|---|---|---|---|---|---|
| Intra-ocular injectionSurgical and medical procedures | 0/243 | 1/129 | 2/127 | 1/129 | 1/114 | 1/111 | 0/114 |
| Age-related macular degenerationEye disorders | 0/243 | 0/129 | 0/127 | 0/129 | 1/114 | 1/111 | 0/114 |
| Posterior capsule ruptureEye disorders | 0/243 | 0/129 | 0/127 | 0/129 | 1/114 | 0/111 | 0/114 |
| Cholecystitis acuteHepatobiliary disorders | 0/243 | 0/129 | 0/127 | 0/129 | 0/114 | 0/111 | 1/114 |
| CholelithiasisHepatobiliary disorders | 0/243 | 0/129 | 0/127 | 1/129 | 0/114 | 0/111 | 1/114 |
| Breast neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/243 | 0/129 | 0/127 | 0/129 | 0/114 | 0/111 | 1/114 |
| Device dislocationProduct Issues | 0/243 | 0/129 | 1/127 | 0/129 | 1/114 | 0/111 | 0/114 |
| Acute kidney injuryRenal and urinary disorders | 0/243 | 0/129 | 0/127 | 0/129 | 0/114 | 0/111 | 1/114 |
| Lens extractionSurgical and medical procedures | 0/243 | 1/129 | 0/127 | 0/129 | 1/114 | 0/111 | 0/114 |
| Cystoid macular oedemaEye disorders | 0/243 | 0/129 | 1/127 | 0/129 | 0/114 | 0/111 | 0/114 |
| Event | Preoperative | TFNT00 - 1st Eye | TFNT00 - 2nd Eye | TFNT00 - Systemic | SN60AT - 1st Eye | SN60AT - 2nd Eye | SN60AT - Systemic |
|---|---|---|---|---|---|---|---|
| Posterior capsule opacificationEye disorders | 0/243 | 17/129 | 19/127 | 0/129 | 4/114 | 5/111 | 0/114 |
| Intraocular pressure increasedInvestigations | 1/243 | 7/129 | 5/127 | 0/129 | 6/114 | 2/111 | 0/114 |
This analysis population includes all eyes with successful IOL implantation with at least 1 post-operative visit (All-Implanted Analysis Set).
| Age, Continuous(years) | TFNT00 | SN60AT | Total |
|---|---|---|---|
| Mean | 65.8 ± 7.31 | 69.0 ± 6.46 | 67.3 ± 7.09 |
| Sex: Female, Male(Participants) | TFNT00 | SN60AT | Total |
|---|---|---|---|
| Female | 85 | 79 | 164 |
| Male | 44 | 35 | 79 |
| Race/Ethnicity, Customized(Participants) | TFNT00 | SN60AT | Total |
|---|---|---|---|
| White | 113 | 96 | 209 |
| Black or African American | 8 | 11 | 19 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 7 | 1 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Other | 1 | 4 | 5 |
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